K253119
- 510(k) number
- K253119
- Device name
- CoSense ETCO Monitor
- Applicant
- Capnia, Inc. CA · US
- Product code
- CCJ — Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Decision date
- 2026-05-29
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253119.pdf
Official FDA record: K253119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.